Levoketoconazole (lee-voe-kee-toe-KON-a-zole)

Treats hypercortisolemia (high cortisol levels) in patients with Cushing syndrome.

Brand Name(s):

Recorlev

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose, skip the missed dose and take your next dose at the regular time. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with alfentanil, avanafil, bosutinib, buspirone, cisapride, clarithromycin, cobimetinib, conivaptan, crizotinib, dabigatran, darifenacin, darunavir, digoxin, disopyramide, dofetilide, dronedarone, ebastine, eliglustat, everolimus, fexofenadine, ibrutinib, ivabradine, lomitapide, lovastatin, lurasidone, methadone, midazolam, midostaurin, naloxegol, nicardipine, nisoldipine, pimozide, quinidine, ranolazine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir, triazolam, or vardenafil.
• Some medicines can affect how levoketoconazole works. Tell your doctor if you are using atorvastatin, metformin, sucralfate, or stomach medicine
• Do not take carbamazepine, efavirenz, isoniazid, mifepristone, mitotane, nevirapine, phenytoin, rifabutin, rifampicin, ritonavir, ritonavir-boosted darunavir, and ritonavir-boosted fosamprenavir 2 weeks before and during treatment with levoketoconazole.
• Take antacids (including aluminum hydroxide) at least 2 hours after you take this medicine.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you have heart rhythm problems.
• Do not breastfeed during treatment and for 1 day after the last dose.
• This medicine may cause the following problems:
  • Liver problems
  • Heart rhythm problems (including QT prolongation)
  • Adrenal gland problems
  • Decreased testosterone levels
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, severe headache, slow, fast, or uneven heartbeat, lightheadedness, dizziness, fainting
• Changes in skin color, dark freckles, cold feeling, weakness, tiredness, weight loss
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dry mouth, increased thirst, muscle cramps
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Inability to have or keep an erection, loss in sexual ability, desire, drive, or performance
• Rapid weight gain, swelling in your hands, ankles, or feet
• Swelling of the breasts in men and women
• Unusual bleeding or bruising
• Weight gain around your neck, upper back, breast, face, or waist

If you notice these less serious side effects, talk with your doctor:

• Back, joint, or muscle pain
• Stomach upset
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088